Oral instant film and preparation method thereof

Abstract

The invention discloses an oral instant film suitable for pet nutrition intervention and a preparation method of the oral instant film, and belongs to the technical field of pet oral preparations. The instant film adopts a sandwich type multi-layer structural design, sequentially comprises a first food calling layer, a core layer and a second food calling layer, can be selectively provided with a functional layer and an interface middle layer, and constructs a staggered hot-pressing laminated structure, so that the structural stability and the function delivery efficiency of a film body are remarkably improved. The core layer contains multiple composite active ingredients such as L-carnitine, coenzyme Q10, beta-glucan, glucosamine sulfate and the like, chitosan-inulin-polyglutamic acid or starch is adopted for embedding to form a first microcapsule and a second microcapsule, and intelligent delivery of temperature / pH response and gastrointestinal controlled release is achieved. The food calling layer is composed of chicken powder, fish oil powder, fructo-oligosaccharide and the like, and the feeding compliance of pets is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of oral preparations, in particular to an oral fast-dissolving film and a preparation method thereof. Background Art

[0002] Currently, in the field of pet nutrition and health products, functional nutritional supplements and health care interventions for companion animals such as dogs and cats are developing in the direction of convenience, precision, and efficiency. Existing pet nutritional products are mainly in the form of tablets, powders, granules, pastes, and liquids. Although these traditional dosage forms are widely used, they still have many problems in actual use. First, some pets have a strong resistance to traditional feeding methods, especially when taking foreign objects or nutritional products with a specific smell and taste. Pet owners often need to use forced means to assist in eating, which can easily trigger a stress response in pets, resulting in low compliance and affecting long-term use effects.

[0003] Secondly, the functions of existing pet nutrition products are generally relatively simple, usually only targeting basic nutritional supplements such as vitamins and minerals, which are difficult to meet the multi-dimensional health management needs of pets in terms of heart health, immune regulation, skin care, bone and joint protection, etc. For pets that require comprehensive conditioning, traditional products often cannot achieve synergistic functions. Users need to purchase different types of products separately, which increases the complexity of use. In addition, the stability of active ingredients has always plagued the research and development and application of pet nutrition products. Many functional ingredients such as coenzyme Q10, L-carnitine, soy isoflavones, etc. are highly sensitive to environmental conditions and are prone to degradation during production, storage and transportation, resulting in weakened or ineffective functions, thereby reducing product quality and actual effects.

[0004] At the same time, pets' exceptionally keen senses of taste and smell make product design challenging. Some functional ingredients inherently have bitter or fishy characteristics, and even masking them with a single sweetener or flavoring cannot completely eliminate the odor, posing a risk of pets rejecting the food. To address pets' poor feeding compliance, some products incorporate attractants such as meat meal, fish oil, and yeast extract. While these can improve palatability to a certain extent, the overall flavor design remains relatively monotonous, making it difficult to adapt to the individual taste needs of different pets.

[0005] Furthermore, current pet nutrition products remain relatively crude in terms of structure and functional release. They generally utilize a homogenous, integrated release model, lacking stratified control and targeted release. This model easily leads to interference between different functional ingredients, resulting in uncontrollable release rates and low absorption efficiency, ultimately impacting functional performance. This issue is particularly prominent in complex formulas, hindering the synergistic effects of multifunctional ingredients and making it difficult to achieve more precise nutritional interventions.

[0006] Therefore, there is an urgent need for a pet nutrition product that is multifunctional, has layered release, strong palatability and stable active ingredients, and can meet the needs of systematic, refined and efficient nutritional intervention in modern pet health management. Summary of the Invention

[0007] In view of the shortcomings of the prior art, the present invention aims to provide an orally disintegrating film and a preparation method thereof.

[0008] The above-mentioned object of the present invention is achieved through the following technical solutions:

[0009] An orally disintegrating film comprises a first food-attracting layer, a core layer, and a second food-attracting layer arranged in sequence, wherein the core layer comprises the following components in parts by weight:

[0010]

[0011] An active ingredient selected from at least one of the following active ingredients A, B, C, and D, specifically:

[0012] Active ingredient A (a composition for promoting heart health) comprises 3 to 3.5 parts of L-carnitine, 0.33 to 0.35 parts of hawthorn extract, 3 to 3.5 parts of taurine, 0.03 to 0.035 parts of coenzyme Q10, and 3 to 3.5 parts of arginine;

[0013] Active ingredient B (composition for improving skin condition) includes 3-3.5 parts of soy lecithin, 3-3.5 parts of aloe vera extract, 0.03-0.035 parts of zinc gluconate, 0.03-0.035 parts of coenzyme Q10, and 0.33-0.35 parts of niacinamide;

[0014] Active ingredient C (a composition for enhancing immune function) comprises 33.3 to 33.5 parts of β-glucan and 33.3 to 33.5 parts of astragalus extract;

[0015] Active ingredient D (a composition for improving bone and joint health) comprises 6-7 parts of glucosamine sulfate, 3-3.5 parts of chondroitin sulfate, 1.2-2 parts of drynaria extract, and 1.2-2 parts of soy isoflavones;

[0016] and a PVP K25-anhydrous ethanol solution for film formation and bonding. The PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 10% to 30% of the total weight of the slurry.

[0017] The functional oral instant film described in the present application realizes the synergistic improvement of structural stability, functional delivery and pet behavior guidance through the sandwich structure design of the first attractant layer, the core layer and the second attractant layer, and significantly optimizes the comprehensive performance of the pet oral instant film product. First of all, this structure breaks the limitations of the existing oral film single layer or simple double layer structure in functional integration and delivery control, and designs different functional areas in different areas. Through a clear hierarchical structure, a multifunctional and efficient synergistic compound effect is achieved. The first and second attractant layers are made of highly attractive raw materials (such as chicken meal, fish oil powder, etc.), which not only effectively attract pets to spontaneously lick and chew, significantly improve the pet's compliance with the intake of the product, but also enhance the overall taste experience through the double-sided attractant design to meet the differentiated needs of different pet breeds and individuals. This design effectively solves the problem of low compliance of existing pet oral film products due to insufficient attractant, making pets more willing and more proactive in accepting oral care and functional delivery products.

[0018] Secondly, the core layer utilizes a scientific blend of sodium bicarbonate, anhydrous citric acid, lactose, sucrose powder, and aspartame. While ensuring a pleasant taste, the reaction between sodium bicarbonate and anhydrous citric acid produces moderate carbon dioxide bubbles, creating a mild stimulation that further enhances pets' licking interest. Furthermore, the addition of cross-linked polyvinylpyrrolidone plays a key role in ensuring the film's structural stability and disintegration rate, ensuring rapid dissolution in the pet's mouth without leaving any residue, thereby enhancing the user experience. The use of PVP K25 in anhydrous ethanol solution as a film-forming and binding agent effectively improves the film's mechanical strength and flexibility, achieving an optimal balance between thickness, ductility, and solubility for the instant film, meeting the needs of different pets.

[0019] The core layer can also flexibly add active ingredients A (promoting heart health), B (improving skin condition), C (enhancing immune function), and D (improving bone and joint health) according to the different health needs of pets, forming a targeted and precise nutritional conditioning plan. The above active ingredients are all high-quality nutritional factors widely verified in pet functional foods, and their bioavailability and delivery effect are ensured through scientific ratios and dosage control. In particular, the integration of these active ingredients in a single core layer greatly improves the functional integration of the product, meets the comprehensive conditioning needs of pets at different physiological stages, and solves the problem that existing single-functional products are difficult to simultaneously meet multiple health needs.

[0020] Overall, the functional oral fast-dissolving film provided in this application effectively improves pet intake compliance, delivery efficiency, and physiological conditioning effects through its compartmentalized structural design, integrated functional modules, and intelligent active ingredient combination. Compared to existing technologies, its innovation lies not only in the multifunctional integration of structural design and the scientific interlayer ratio, but also in the systematic health management achieved through the coordinated delivery of multifunctional active ingredients, demonstrating significant technological advancement and application prospects.

[0021] Furthermore, the orally disintegrating film has a thickness of 20 μm to 200 μm.

[0022] The orally disintegrating film described in this application achieves comprehensive optimization of structural stability, ease of use, and functional delivery efficiency by controlling the film thickness between 20μm and 200μm. This thickness range ensures the film has good flexibility and mechanical strength, allowing the product to quickly adhere and dissolve after contact with the pet's tongue or oral mucosa, improving the pet's compliance and comfort. In particular, the thinner film design can achieve instant dissolution, meeting the requirements of rapid release and efficient absorption, and is suitable for pets of different body sizes and feeding behaviors.

[0023] At the same time, flexible control of film thickness supports the precise delivery of different functional ingredients. By adjusting the thickness, not only can the active ingredient loading be optimized and uniform release be ensured, but it can also be combined with intelligent controlled-release design to achieve phased delivery and progressive release, further improving bioavailability. The set thickness range also enhances the structural integrity of the film during production, transportation, and use, preventing film breakage or uneven disintegration, and ensuring the stability and consistency of product quality.

[0024] Furthermore, the active ingredients include four active ingredients A, B, C, and D, and the active ingredients A and B are pre-embedded into a first microcapsule using chitosan, and the active ingredients C and D are pre-embedded into a second microcapsule using starch.

[0025] Furthermore, the embedding material of the first microcapsule also contains inulin and polyglutamic acid, and the specific steps are as follows:

[0026] a) dissolving chitosan in an acetic acid aqueous solution to obtain a chitosan solution;

[0027] b) adding an inulin solution and a polyglutamic acid solution to the chitosan solution to form a chitosan-inulin-polyglutamic acid composite solution;

[0028] c) adding the active ingredient A and / or active ingredient B weighed in proportion to the composite solution obtained in step b) and stirring to form a suspension;

[0029] d) adding the suspension obtained in step c) dropwise to an alkaline coagulation solution to form microcapsules;

[0030] e) washing and drying the obtained microcapsules to obtain active ingredient microcapsules with temperature-responsive and pH-responsive functions.

[0031] The functional orally disintegrating film disclosed in this application integrates first and second microcapsules within the core layer, creating a phased, intelligently responsive delivery system for multifunctional active ingredients. This system enables systematic conditioning and precise control of diverse pet health needs. This delivery system not only improves the bioavailability and efficacy of the active ingredients but also, through structural design and functional integration, forms a complete closed-loop system from material selection to delivery control and ultimately physiological function realization.

[0032] The first microcapsule in the core layer is primarily used to deliver active ingredients A (promoting heart health) and B (improving skin condition). Chitosan is used as the encapsulation material, and inulin and polyglutamic acid (PGA) are introduced in combination, which not only enhances the stability of the microcapsule structure but also imparts intelligent response properties. Chitosan exhibits excellent pH responsiveness and rapidly expands and swells under the temperature conditions of the pet's oral environment (pH 5.5-6.5) and licking behavior, promoting the rapid release of the active ingredients. Inulin, a natural oligosaccharide with high hydrophilicity and a flexible chain structure, can significantly regulate the swelling behavior and release sensitivity of the microcapsules. By adjusting the length of the inulin molecular chain, not only can precise control of different temperature response thresholds be achieved, but a dual-responsive system of temperature and enzyme sensitivity is also formed, ensuring that the microcapsules respond quickly and initiate the release mechanism in the pet's oral environment (temperature around 37°C, pH 5.5-6.5). At the same time, inulin has prebiotic properties, which, while delivering active ingredients, contributes to the proliferation of beneficial intestinal bacteria in pets, enhancing their overall immunity and digestive health. Polyglutamic acid (PGA) is a highly water-soluble, biodegradable natural polymer. Its molecular structure is rich in a large number of carboxyl groups, which can form a stable hydrogen bond network with chitosan, significantly improving the stability and mechanical strength of the microcapsule structure. More importantly, PGA has a significant ability to regulate temperature response. By regulating the degree of molecular cross-linking, the thermal response window of the microcapsule can be accurately set, so that the microcapsule can achieve the optimal release trigger point within the range of 38°C to 42°C. This feature ensures that under the conditions of slightly elevated temperatures caused by the pet's oral temperature environment and licking behavior, the microcapsule can instantly identify and respond, achieving the first stage of intelligent release. At the same time, PGA itself has certain immunomodulatory and oral repair functions. While delivering nutritional active ingredients, it can assist in improving the pet's oral environment, inhibit local inflammatory responses, enhance the self-repair ability of the oral mucosa, and further enhance the comprehensive health benefits of the product.

[0033] The synergistic combination of inulin and polyglutamic acid creates an intelligent controlled-release system with stable structure, sensitive response and complex functions, realizing the precise delivery control of the first microcapsule in the oral environment. The microcapsule quickly disintegrates under the acidic conditions and elevated temperature of the oral cavity, releasing L-carnitine, hawthorn extract, taurine, coenzyme Q10, arginine (active ingredient A) and soy lecithin, aloe extract, zinc gluconate, and niacinamide (active ingredient B), achieving rapid conditioning of pets' heart function and immediate improvement of their skin condition. Its intelligent controlled-release and rapid absorption characteristics solve the problems of lag and inefficiency in the previous delivery of active ingredients, greatly improving the immediacy and accuracy of nutritional conditioning.

[0034] The second microcapsule is designed for active ingredients C (enhancing immune function) and D (improving bone and joint health), using starch as a composite embedding material to form a progressive controlled release system. The microcapsule remains stable in the oral cavity and slowly releases some ingredients under the action of salivary amylase to achieve local sustained release. After entering the gastrointestinal tract, the starch matrix is controlled by gastrointestinal enzymatic hydrolysis and pH environmental changes, and the active ingredients are released in segments. The β-glucan and astragalus extract in the active ingredient C complete progressive release in the small intestine to enhance the immune system regulation function. The glucosamine sulfate, chondroitin sulfate, drynaria extract, soy isoflavones, etc. in the active ingredient D achieve long-term nutritional supply and functional improvement of bones and joints through segmented sustained release in the gastrointestinal tract, meeting the needs of pet chronic diseases and elderly health management.

[0035] The phased response mechanism of the first and second microcapsules enables a dynamic delivery pathway from the oral cavity to the gastrointestinal tract, resolving issues such as mismatched active ingredient release times and unclear delivery targets in existing delivery systems. Through independent microencapsulation processes, each active ingredient forms an independent response control system, and the core layer slurry is added in appropriate proportions according to the formulation design, ensuring the timely delivery and precise dosage of different active ingredients.

[0036] Furthermore, the first food attracting layer and the second food attracting layer are both prepared from the following raw materials in parts by weight:

[0037] Chicken or duck powder: 5-15 servings

[0038] Fish oil powder or shrimp powder: 2-10 parts

[0039] Mannitol or xylitol: 5-10 parts

[0040] Fat emulsion or lecithin: 1-5 parts

[0041] Fructooligosaccharides: 3-8 parts

[0042] Yeast extract: 0.1-1 part

[0043] Deionized water: 30-60 parts.

[0044] The first and second attractant layers are prepared based on a scientific and reasonable formula system, including chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose and yeast extract. The synergistic application of all raw materials not only enhances the product's attractant and taste experience, but also takes into account the adaptability to the pet's oral environment and health protection needs.

[0045] The precise combination of animal protein and lipid ingredients, such as chicken meal, duck meal, fish oil powder, or shrimp meal, effectively stimulates a pet's natural olfactory sensitivity and appetite reflex. These ingredients, rich in plant and animal proteins and lipid compounds, instantly release a delicious flavor on the pet's tongue, quickly inducing licking or chewing behavior. The introduction of fat emulsion or lecithin not only enhances the film's flexibility and disintegration comfort, but also further improves its dissolution rate and lubricity in the oral environment, preventing the sensation of a foreign body and thus enhancing pet acceptance and compliance.

[0046] Furthermore, the addition of mannitol or xylitol not only enhances the film's sweetness and texture, but also moisturizes the mouth and promotes salivation, optimizing film disintegration and active ingredient release. Fructooligosaccharides fully exploit their prebiotic properties, helping to balance oral and intestinal flora in pets, ensuring both nutritional and nutritional benefits while stimulating appetite. Yeast extract, a natural flavor enhancer and immunomodulator, further strengthens the film's overall sensory appeal and nutritional value.

[0047] Through rational raw material ratios and process control, this attractant layer system not only ensures the integrity and interlayer adhesion strength of the first and second attractant layers within the film structure, but also exhibits rapid disintegration and high attractant properties, significantly increasing the likelihood of active licking and feeding behaviors in pets. The film quickly adheres and dissolves upon contact with the pet's tongue. Combined with highly attractive flavor ingredients, it effectively activates feeding behavior within 1 to 5 seconds, creating an optimal delivery environment for the subsequent release and absorption of active ingredients.

[0048] Furthermore, a functional layer is provided between the core layer and the first attractant layer, and the functional layer is prepared by including the following raw materials in parts by weight:

[0049] Tea polyphenols: 1-5 parts

[0050] Lactoferrin: 0.5-3 parts

[0051] β-glucan: 2-6 parts

[0052] Sodium bicarbonate: 3-8 parts

[0053] Mannitol: 5-15 parts

[0054] Soluble dietary fiber: 2 to 6 servings

[0055] Gelatin: 2-5 parts

[0056] Deionized water: 30-60 parts.

[0057] The oral fast-dissolving film described in this application incorporates a functional layer between the core layer and the first attractant layer. This layer contains a variety of functional ingredients, including tea polyphenols, lactoferrin, β-glucan, sodium bicarbonate, mannitol, soluble dietary fiber, gelatin, and deionized water. Through scientific compatibility and layered structural optimization, it achieves multiple technical benefits: oral cleansing, antibacterial and deodorizing, local immune regulation, and delivery route optimization. This functional layer overcomes the limitations of existing pet oral health products, which are characterized by single functions and superficial effects, and establishes an integrated delivery chain of "behavior induction-oral care-functional delivery," significantly enhancing the product's overall performance and user experience.

[0058] This functional layer first forms a key intermediary for zoned controlled release in structural design, located between the first attractant layer and the core functional layer, acting as an effective functional transition and delivery buffer. When the pet activates the dissolution of the first attractant layer through licking, the functional layer is quickly exposed and dissolves, releasing key active factors such as tea polyphenols, lactoferrin, and β-glucan into the local oral environment. This process is efficiently completed within 5 to 10 seconds, providing preliminary cleaning, antibacterial, and antioxidant effects to the pet's oral environment, inhibiting the growth of harmful oral bacteria, reducing oral odor, and optimizing the oral microecological balance.

[0059] Tea polyphenols possess excellent antioxidant and broad-spectrum antibacterial properties, quickly forming a protective film on the oral mucosa of pets, inhibiting plaque formation and the accumulation of bacterial metabolites, effectively preventing bad breath and oral infections. Lactoferrin, by binding to free iron ions, inhibits bacterial growth and exhibits significant anti-inflammatory and immunomodulatory effects, further promoting the restoration and maintenance of oral health in pets. Furthermore, β-glucan, a natural immune activator, not only boosts local oral immunity but also, to a certain extent, induces a systemic immune response, laying the foundation for the subsequent delivery of active ingredients in the core layer and systemic health conditioning.

[0060] The addition of sodium bicarbonate gives the functional layer excellent acid-base regulation, neutralizing the acidity of the oral environment and reducing the risk of tooth demineralization and caries. Mannitol enhances the taste experience while promoting saliva secretion, increasing the rate of film disintegration and the diffusion of active ingredients, and effectively accelerating the release and action of the functional layer substances. The synergistic effect of soluble dietary fiber and gelatin further enhances the film's flexibility, ensuring stable adhesion and uniform disintegration of the film on the tongue and oral mucosa, avoiding film residue and foreign body sensation, and improving the comfort of pets licking and ingesting.

[0061] Furthermore, an interface intermediate layer is provided between the first attracting layer, the core layer and the second attracting layer, and the raw materials of the interface intermediate layer include the following components in parts by weight:

[0062] Gelatin: 5-10 parts;

[0063] Polyvinyl alcohol: 2-8 parts;

[0064] Glycerin: 1-5 parts;

[0065] Deionized water: 30-60 parts;

[0066] The thickness of the interface intermediate layer is 5 to 20 μm.

[0067] The functional orally disintegrating film described in this application incorporates an interfacial interlayer between the first food-attracting layer, the core layer, and the second food-attracting layer. This interfacial interlayer is composed of materials such as gelatin, polyvinyl alcohol, glycerin, and deionized water, with a thickness controlled within the range of 5 to 20 μm. This design effectively enhances the structural integrity and interlayer adhesion of the multilayer film, improving the product's physical stability during processing, storage, and use. It prevents film rupture, breakage, or delivery failure caused by interlayer structural separation or uneven material expansion, significantly improving the product's overall quality and user experience.

[0068] The key technical advantage of the interface intermediate layer is first reflected in its buffering and protective effect. Due to the different functional components and carrier material properties contained in different film layers, their swelling rates, disintegration behaviors and water permeability are different, which can easily cause interlayer peeling or film structure damage due to stress concentration or moisture gradient during use. This application provides a flexible interface intermediate layer between different functional layers to effectively buffer and absorb structural stress, maintain a dynamic balance between the layers, prevent delamination and fracture, and ensure the integrity and continuity of the film during operation and ingestion.

[0069] The interface middle layer uses gelatin as the basic film-forming material, which has good biocompatibility and edibility, and can provide stable structural support for the multilayer film. Polyvinyl alcohol (PVA) further improves the mechanical strength and moisture resistance of the film layer, significantly enhances the interlayer bonding force, and ensures that the film body maintains a tight interlayer structure in a high-humidity environment (such as a pet's mouth) to avoid layer separation. Glycerol acts as a plasticizer and humectant to enhance the flexibility and palatability of the film body, while ensuring that the interface middle layer has good ductility and flexibility, conforms to the stress changes between the film layers, and improves the dynamic adaptability of the overall structure.

[0070] In terms of delivery performance, the interfacial intermediate layer regulates the diffusion paths of water and solutes, acting as an interlayer controlled release regulator. The thickness and composition of the interfacial intermediate layer are precisely designed to effectively control water penetration and the diffusion rate of active ingredients as the first attractant layer, functional layer, or core layer dissolves, achieving zonal regulation of the delivery rhythm and progressive release, thereby improving the delivery accuracy and bioavailability of multifunctional active ingredients. This zonal controlled release design enables the membrane to form a layered release and gradient delivery path during the delivery process, optimizing the overall nutrient delivery efficiency and effectiveness.

[0071] In addition, the presence of the interfacial intermediate layer improves the controllability of the film's processing technology. Due to its good rheological properties and uniform film-forming properties, the functional layers maintain uniform thickness and tight bonding during key steps such as coating, drying, and hot pressing, improving the consistency and batch stability of the multi-layer film structure and reducing the product defect rate during the manufacturing process. The standardized thickness control of the interfacial intermediate layer (5-20μm) ensures that it will not adversely affect the overall thickness of the film and the oral dissolution experience, while providing maximum interlayer structural stability.

[0072] Furthermore, the oral fast-dissolving film adopts a staggered laminated structure, specifically comprising:

[0073] a) The first attractant layer, the core layer, and the second attractant layer are stacked in sequence, with at least two interlaced sections, each of which is 20% to 50% of the total membrane length;

[0074] b) In the staggered section, the first attractant layer extends beyond the core layer by 5 to 10 mm, and the second attractant layer extends beyond the core layer by 5 to 10 mm, forming a stepped edge;

[0075] c) forming a hot pressing bonding belt in the staggered section, using a hot pressing process at 40-60° C., a pressure of 0.1-0.5 MPa, and a hot pressing time of 5-15 seconds;

[0076] d) When the multilayer film is cut, the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone, and the effective area of a single film is 2 to 5 cm 2 .

[0077] In terms of structural design, the first attractant layer, the core layer, and the second attractant layer are offset in a stepped manner in multiple staggered sections of the membrane, forming a visually recognizable edge structure. The main ingredients in the first and second attractant layers include highly attractant and sensory stimulating ingredients such as chicken meal, fish oil powder, mannitol, and oligofructose, which extend 5 to 10 mm beyond the core layer in the staggered structure and are located in the outermost dissolution leading position. Because these raw materials have good water solubility and strong flavor release capabilities, they can quickly dissolve and release fragrance and taste factors after the tip of the tongue contacts saliva, preferentially stimulating pets' licking and feeding behaviors. The protruding edges of the structure not only speed up the contact and dissolution speed of these ingredients, but also form a physical "bite guide point" to improve the efficiency of initiating feeding behavior.

[0078] The core layer in the middle of the membrane is structurally surrounded by the attractant layers on both sides, and carries the active ingredients A and B embedded in chitosan-inulin-PGA, and the active ingredients C and D embedded in starch / gelatin. In the staggered structure, the core layer is designed to be slightly smaller than the main structure of the outer layer, forming a stable interlayer lock in the hot-pressed bonding zone. This structure, combined with the pH responsiveness and temperature-sensitive properties of the ingredients themselves, allows the core layer to be gradually exposed after the gradual disintegration of the attractant part of the outer layer, thereby achieving progressive release of functional ingredients. For example, ingredients such as L-carnitine, taurine, and hawthorn extract embedded in the first microcapsule can be quickly released in the oral temperature and acidic environment to enhance the heart function support effect; while β-glucan, glucosamine sulfate, etc. are continuously released in the gastrointestinal tract through the second microcapsule to complete the functions of immune regulation and bone and joint nutrition.

[0079] More importantly, the heat-pressing of the staggered segments not only stabilizes the physical structure but also acts as a synergistic buffer for ingredient release and rhythmic control. Within the tightly packed interlayers formed by heat pressing, the membrane's permeability to water and the diffusion rate of the ingredients are naturally regulated. Water released from the attractant layer is guided through the staggered zones and slowly permeates into the core layer, effectively delaying the premature release of the core active ingredient. This ensures that the rhythms of the behavioral induction and functional delivery phases are staggered and non-overlapping, thus avoiding reduced bioavailability or release interference.

[0080] In addition, the area of the single membrane formed after shearing is controlled within 2 to 5 cm 2 The edges retain a complete set of staggered steps and heat-pressed bands, creating a clear, logical layering structure. This not only enhances the visual appearance but also provides a better sense of structure and behavioral guidance during handling and feeding. Pets of different sizes can sense the membrane along the edges when ingesting it, naturally licking or chewing along the preset direction, strengthening their behavioral control and improving product compliance.

[0081] A method for preparing an orally disintegrating film comprises the following steps:

[0082] S1: preparing core layer slurry;

[0083] Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and at least one active ingredient selected from active ingredients A, B, C, and D in parts by weight, mix well, add PVPK25-anhydrous ethanol solution, and stir to form a uniform slurry;

[0084] S2: preparing the first attractant layer slurry;

[0085] Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry;

[0086] S3: preparing the second attractant layer slurry;

[0087] The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps;

[0088] S4: preparing functional layer slurry;

[0089] Weigh tea polyphenols, lactoferrin, β-glucan, sodium bicarbonate, mannitol, soluble dietary fiber, and gelatin according to weight, add deionized water, and stir to mix to prepare a functional layer slurry;

[0090] S5: preparing interface intermediate layer slurry;

[0091] Weigh gelatin, polyvinyl alcohol, and glycerin according to weight, add deionized water, and stir to mix to prepare an interface intermediate layer slurry;

[0092] S6: lamination film formation;

[0093] On the pre-treated film-forming substrate, the first attracting layer slurry, the core layer slurry and the second attracting layer slurry are sequentially spread to form a three-layer structure;

[0094] S7: hot pressing treatment;

[0095] The laminated film is hot-pressed at a temperature of 40 to 60° C. and a pressure of 0.1 to 0.5 MPa for 5 to 15 seconds to form a staggered laminated structure, a stepped edge, and a hot-pressed bonding zone.

[0096] S8: Drying treatment;

[0097] Dry the hot-pressed film at 40°C for 4 to 6 hours to control the moisture content of the film below 5%;

[0098] S9: Cutting and Packaging

[0099] Cut the dried film to ensure that the effective area of a single film is 2 to 5 cm 2 , the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone;

[0100] Finally, the product is packaged and sealed to obtain the oral fast-dissolving film.

[0101] The preparation method described in this application includes multiple steps from the preparation of slurry for the core layer, the first attractant layer, the second attractant layer, the functional layer, and the interface intermediate layer, to the lamination, hot pressing, drying, cutting, and packaging of the film, forming a complete manufacturing path for the film construction and functional delivery carrier, fully ensuring the technical effects of the film in terms of structural integrity, functional delivery efficiency, oral adaptability, and ingredient stability.

[0102] The film lamination process uses coating and spreading technology to arrange each functional layer in sequence on the film-forming substrate. The thickness of each layer is precisely controlled according to the different slurry viscosities and rheological properties to ensure that the first attractant layer, core layer, second attractant layer, and intermediate functional layer (if provided) present a complete stacking sequence in structure. This method allows the formation of a 20-100μm attractant layer, a 50-150μm core layer, and a 5-20μm intermediate layer structure under fixed thickness control, making the overall thickness of the film both palatable and having sufficient drug loading capacity, while taking into account oral compatibility and disintegration speed.

[0103] The hot pressing process is set to 40-60°C, 0.1-0.5MPa, and 5-15 seconds, which can form a stable hot pressing bonding belt in the staggered section, effectively improving the adhesion strength and edge sealing performance between the film layers.

[0104] In the drying process, the film is gently dehydrated by controlling the temperature and time (such as 40°C, 4 to 6 hours), so that the final moisture content is controlled below 5%, avoiding embrittlement, shrinkage or inactivation of active ingredients caused by high temperature or over-drying. In the final cutting and packaging step, standardized cutting of 2 to 5 cm is carried out on the basis of maintaining the integrity of the hot-pressed bonding band and the interlaced structure. 2 The diaphragm unit ensures that each piece has accurate dosage, regular edges, and is easy to use, suitable for different pet sizes and feeding needs.

[0105] Furthermore, in step S1, before the active ingredient A and / or active ingredient B is added to the core layer slurry, the first microcapsules are prepared in advance by the following microcapsule embedding method:

[0106] a1) dissolving chitosan in an aqueous acetic acid solution to obtain a chitosan solution;

[0107] a2) adding the inulin solution and the polyglutamic acid solution to the chitosan solution to form a composite solution;

[0108] a3) adding active ingredient A and / or active ingredient B weighed in proportion to the composite solution and stirring to form a suspension;

[0109] a4) adding the suspension dropwise to the alkaline coagulation solution to form first microcapsules;

[0110] a5) washing and drying the obtained microcapsules to obtain first microcapsules with temperature-responsive and pH-responsive functions;

[0111] In step a), the second microcapsules of active ingredient C and / or active ingredient D are prepared by the following method:

[0112] a6) dissolving starch in deionized water to form a paste;

[0113] a7) adding active ingredient C and / or active ingredient D weighed in proportion and stirring to form a mixed solution;

[0114] a8) preparing second microcapsules by spray drying.

[0115] The preparation method described in this application utilizes differentiated encapsulation techniques for the first and second microcapsules, achieving stable and precise release of active ingredients A, B, C, and D at different delivery stages. This significantly enhances the protective capacity, bioavailability, and timeliness of delivery of the nutritional functional ingredients. This technical solution overcomes the difficulty in uniformly delivering the different functional ingredients in traditional pet nutritional film formulations, establishing a composite release system based on the intelligent response mechanism of microcapsules, combining "ingredient differentiation, pathway separation, and time-staggered delivery."

[0116] In the preparation process of the first microcapsule, chitosan, inulin and polyglutamic acid are used to encapsulate active ingredients A and / or B to form composite microcapsules with dual temperature and pH responsiveness. This preparation route first dissolves chitosan in an acetic acid aqueous solution to construct a basic film-forming system, and then sequentially introduces an inulin solution and a polyglutamic acid solution to form a network-crosslinked composite carrier solution. After the active ingredients A (such as L-carnitine, hawthorn extract, taurine, etc.) and B (such as soy lecithin, aloe extract, niacinamide, etc.) are added and uniformly stirred to form a suspension, which is then added dropwise to an alkaline coagulation solution to prepare molded microcapsules. After washing and drying, the first microcapsules with good structural density and response control capabilities are obtained.

[0117] In this microcapsule system, chitosan is the primary scaffold material, giving the microcapsules pH sensitivity; polyglutamic acid, through its abundant carboxyl groups, forms a stable hydrogen bond network with chitosan, improving the mechanical strength and thermal response control capabilities of the microcapsules; inulin has good hydrophilicity and molecular chain flexibility, which not only improves the temperature sensitivity of disintegration rate control, but also has prebiotic functions, strengthening intestinal health support after the ingredients are released. The composite structure formed by the three synergistically enables the microcapsules to rapidly swell and disintegrate in the weakly acidic environment of the mouth and the temperature changes caused by licking (≥37°C), achieving the targeted and rapid release of the first-stage functional ingredients, suitable for heart health and skin care functions that require immediate intervention.

[0118] The second microcapsule uses starch as the primary encapsulation matrix, supplemented with gelatin for structural stabilization. Active ingredients C (such as β-glucan and astragalus extract) and D (such as glucosamine sulfate, chondroitin, and soy isoflavones) are encapsulated via spray drying. This encapsulation system exhibits significant enzyme responsiveness and pH dependence, remaining essentially stable in the oral environment to avoid early release interference. In the gastrointestinal tract, the active ingredients are gradually released based on the enzymatic hydrolysis rate and pH environment, forming a second phase of progressive release.

[0119] Specifically, the starch material is gradually broken down by salivary amylase and intestinal digestive enzymes in the gastrointestinal tract, loosening the microcapsule structure layer by layer and achieving continuous and directional delivery. Gelatin, through its cross-linked structure, imparts overall morphological stability and coating efficiency to the microcapsules, allowing active ingredients C and D to remain active after passing through the acidic environment of the stomach and achieve functional release in target areas such as the small and large intestines. This microcapsule system is suitable for chronic immune regulation and medium- to long-term support of bone and joint function, establishing a "delayed release-targeted absorption" delivery rhythm.

[0120] By proportionally introducing the first and second microcapsules into the core layer slurry, this application constructs a dual-microcapsule intelligent delivery system: the first microcapsule is responsible for rapid oral release, activating the action and providing immediate functional support; the second microcapsule achieves sustained release in the gastrointestinal tract, completing long-term conditioning and maintaining systemic function. The two are independently controllable in the preparation path and closely linked in the delivery rhythm, ensuring the spatial separation, time-staggered delivery, and targeted delivery of different functional ingredients, thereby significantly improving the overall bioavailability and nutritional intervention effect of the product.

[0121] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in the following aspects:

[0122] The oral fast-dissolving film of the present invention constructs a sandwich-type multi-layer structure including a first attractant layer, a core layer, and a second attractant layer, and introduces functional layers, interface intermediate layers, and staggered stacking designs between different layers, as well as a double-microcapsule intelligent encapsulation system. It implements closed-loop control from structural construction to delivery implementation, from material selection to functional release, thereby solving the core problems of existing pet nutrition delivery methods such as low compliance, poor utilization efficiency of functional ingredients, and insufficient control of delivery rhythm.

[0123] The present invention significantly enhances the probability of initiating pet feeding behavior through the mirrored arrangement and flavor formula design of the first and second attractant layers. Combined with the synergistic effect of highly attractant ingredients (such as chicken meal, fish oil powder, oligosaccharides, etc.), licking behavior occurs quickly within 1 to 5 seconds, effectively improving compliance with the medication. The core layer serves as the functional delivery body. By introducing active ingredients A, B, C, and D and adopting a double microencapsulation strategy, it achieves a two-stage delivery path of "rapid oral absorption + progressive gastrointestinal release", meeting the comprehensive nutritional conditioning needs of pets in the heart, skin, immune, joints and other systems. The first microcapsule (chitosan-inulin-PGA composite material) in the microencapsulation system has dual pH and temperature response capabilities, and can quickly swell and release active ingredients under oral temperature and acidic environment, which is suitable for the fast-acting requirements of oral mucosal absorption; the second microcapsule (gelatin-starch based) is progressively released under gastrointestinal enzymatic hydrolysis and pH environment, and is used for the stable delivery of long-term conditioning ingredients. The differentiated structural and functional designs of the two enable the multifunctional delivery to have the ability of partition control and timing coordination, and construct a multi-dimensional delivery pathway of "peak-shifting release-partitioned absorption".

[0124] Secondly, the staggered stacking structure is used to arrange the membrane layers in an staggered manner and combine them with hot pressing, which not only enhances the physical strength and interlayer adhesion of the membrane, but also realizes a logical closed loop from food attraction guidance to functional release through the spatial guidance of structural hierarchy and solubility gradient, effectively avoiding the problems of ingredient mixing and uncontrolled disintegration.

[0125] The present invention, through the synergy of structural innovation and functional coupling, constructs a pet oral fast-dissolving film with high compliance, intelligent response, precise function and hierarchical delivery. DETAILED DESCRIPTION

[0126] The present invention is described in detail below with reference to the embodiments.

[0127] Example 1

[0128] An orally disintegrating film comprises a first food-attracting layer, a core layer, and a second food-attracting layer arranged in sequence, wherein the core layer comprises the following components in parts by weight:

[0129]

[0130] Active ingredient A (a composition for promoting heart health) includes 3 parts of L-carnitine, 0.33 parts of hawthorn extract, 3 parts of taurine, 0.03 parts of coenzyme Q10, and 3 parts of arginine;

[0131] and a PVP K25-anhydrous ethanol solution for film formation and bonding, wherein the PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 10% of the total weight of the slurry.

[0132] The first attractant layer and the second attractant layer are both prepared from the following raw materials in parts by weight:

[0133] Chicken powder: 5 servings

[0134] Fish oil powder: 2 parts

[0135] Mannitol: 5 parts

[0136] Fat emulsion: 1 portion

[0137] Fructooligosaccharides: 3 servings

[0138] Yeast extract: 0.1 parts

[0139] Deionized water: 30 parts.

[0140] A method for preparing an orally disintegrating film comprises the following steps:

[0141] S1: preparing core layer slurry;

[0142] Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and active ingredient A according to weight, mix well, add PVP K25-anhydrous ethanol solution, and stir to form a uniform slurry;

[0143] S2: preparing the first attractant layer slurry;

[0144] Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry;

[0145] S3: preparing the second attractant layer slurry;

[0146] The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps;

[0147] S4: lamination film formation;

[0148] On the pre-treated film-forming substrate, the first attractant layer slurry, the core layer slurry and the second attractant layer slurry are spread in sequence to form a three-layer structure; the fixed thickness coating process is used to spread the slurry and control the thickness of each layer as follows:

[0149] First attractant layer: 50 μm;

[0150] Core layer: 100 μm;

[0151] Second attractant layer: 50 μm;

[0152] S5: hot pressing treatment;

[0153] The laminated film was hot pressed at 50°C and 0.1 MPa for 5 seconds.

[0154] S6: Drying treatment;

[0155] The hot-pressed film was dried at 40°C for 4 hours to control the moisture content of the film below 5%.

[0156] S7: Cutting and Packaging

[0157] Cut the dried membrane to ensure that the effective area of a single membrane is 5cm 2 , the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone;

[0158] Finally, the product is packaged and sealed to obtain the oral fast-dissolving film.

[0159] Example 2

[0160] The difference between Example 2 and Example 1 is that the content of ingredients in the first attractant layer, the core layer and the second attractant layer and the selection of active ingredients are different.

[0161] In this embodiment, the core layer includes the following components in parts by weight:

[0162]

[0163] Active ingredient B (composition for improving skin condition) includes 3.3 parts of soy lecithin, 3.3 parts of aloe vera extract, 0.033 parts of zinc gluconate, 0.033 parts of coenzyme Q10, and 0.333 parts of niacinamide;

[0164] and a PVP K25-anhydrous ethanol solution for film formation and bonding, wherein the PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 20% of the total weight of the slurry.

[0165] The first attractant layer and the second attractant layer are both prepared from the following raw materials in parts by weight:

[0166] Duck meat powder: 15 servings

[0167] Shrimp powder: 10 servings

[0168] Xylitol: 10 parts

[0169] Lecithin: 5 parts

[0170] Fructooligosaccharides: 8 servings

[0171] Yeast extract: 1 part

[0172] Deionized water: 60 parts.

[0173] Example 3

[0174] The difference between Example 3 and Example 1 is that the content of ingredients in the first attractant layer, the core layer and the second attractant layer and the selection of active ingredients are different.

[0175] In this embodiment, the core layer includes the following components in parts by weight:

[0176]

[0177] Active ingredient C (a composition for enhancing immune function) comprises 33.4 parts of β-glucan and 33.4 parts of astragalus extract;

[0178] and a PVP K25-anhydrous ethanol solution for film formation and bonding, wherein the PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 30% of the total weight of the slurry.

[0179] The first attractant layer and the second attractant layer are both prepared from the following raw materials in parts by weight:

[0180] Chicken powder: 10 servings

[0181] Fish oil powder: 6 parts

[0182] Mannitol: 7 parts

[0183] Fat emulsion or: 3 servings

[0184] Fructooligosaccharides: 5 servings

[0185] Yeast extract: 0.6 parts

[0186] Deionized water: 45 parts.

[0187] Example 4

[0188] The difference between Example 4 and Example 1 is that the content of ingredients in the first attractant layer, the core layer and the second attractant layer and the selection of active ingredients are different.

[0189] In this embodiment, the core layer includes the following components in parts by weight:

[0190]

[0191]

[0192] Active ingredient D (a composition for improving bone and joint health) comprises 6.5 parts of glucosamine sulfate, 3.3 parts of chondroitin sulfate, 1.6 parts of drynaria extract, and 1.6 parts of soy isoflavones;

[0193] and a PVP K25-anhydrous ethanol solution for film formation and bonding, wherein the PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 30% of the total weight of the slurry.

[0194] The first attractant layer and the second attractant layer are both prepared from the following raw materials in parts by weight:

[0195] Chicken or duck meal: 11 servings

[0196] Fish oil powder or shrimp powder: 8 servings

[0197] Mannitol or xylitol: 7 parts

[0198] Fat emulsion or lecithin: 3 parts

[0199] Fructooligosaccharides: 5 servings

[0200] Yeast extract: 0.6 parts

[0201] Deionized water: 50 parts.

[0202] Example 5

[0203] An orally disintegrating film comprises a first food-attracting layer, a core layer, and a second food-attracting layer arranged in sequence, wherein the core layer comprises the following components in parts by weight:

[0204]

[0205] Active ingredient A (a composition for promoting heart health) includes 3.3 parts of L-carnitine, 0.34 parts of hawthorn extract, 3.4 parts of taurine, 0.033 parts of coenzyme Q10, and 3.3 parts of arginine;

[0206] Active ingredient B (composition for improving skin condition) includes 3.2 parts of soy lecithin, 3.2 parts of aloe vera extract, 0.033 parts of zinc gluconate, 0.033 parts of coenzyme Q10, and 0.34 parts of niacinamide;

[0207] Active ingredient C (a composition for enhancing immune function) comprises 33.4 parts of β-glucan and 33.4 parts of astragalus extract;

[0208] Active ingredient D (a composition for improving bone and joint health) comprises 6.5 parts of glucosamine sulfate, 3.3 parts of chondroitin sulfate, 1.5 parts of drynaria extract, and 1.5 parts of soy isoflavones;

[0209] and a PVP K25-anhydrous ethanol solution for film formation and bonding, wherein the PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 10% of the total weight of the slurry.

[0210] The first attractant layer and the second attractant layer are both prepared from the following raw materials in parts by weight:

[0211] Chicken powder: 5 servings

[0212] Fish oil powder: 2 parts

[0213] Mannitol: 5 parts

[0214] Fat emulsion: 1 portion

[0215] Fructooligosaccharides: 3 servings

[0216] Yeast extract: 0.1 parts

[0217] Deionized water: 30 parts.

[0218] Before the active ingredients A and B are added to the core layer slurry, the first microcapsules are prepared in advance by the following microcapsule embedding method:

[0219] a1) 1 part chitosan was added to 100 parts by volume of a 1.5% aqueous acetic acid solution, and stirred at 400 rpm at 45° C. for 2 hours to completely dissolve the chitosan, thereby obtaining a transparent and uniform chitosan solution.

[0220] a2) Add 5 parts of active ingredient A or active ingredient B to the chitosan solution and continue stirring for 20 minutes to form a uniform suspension. The stirring temperature is controlled to not exceed 40°C to avoid inactivation of the active ingredient.

[0221] a3) adding the suspension dropwise to 100 parts of a 0.3 mol / L sodium hydroxide solution at a rate of 5 parts per minute, and slowly stirring at room temperature to achieve crosslinking and gelation to form first microcapsules with a certain particle size.

[0222] a4) The generated microcapsules were separated by filtration or centrifugation (3000 rpm, 10 minutes), washed three times with deionized water, and then vacuum-dried at 50° C. for 12 hours to obtain dried first microcapsules with good temperature and pH response.

[0223] The active ingredients C and D are prepared into the second microcapsules by the following method:

[0224] a5) Add 5 parts of corn starch to 100 parts of deionized water, stir evenly, and heat to 70°C. Maintain this temperature and stir for 40 minutes to form a transparent paste.

[0225] a6) After the paste is cooled to 45°C, 5 parts of active ingredient C or active ingredient D are added and stirred at 8000 rpm for 15 minutes using a high-speed shearing machine to obtain a stable and uniform embedding mixture.

[0226] a7) The mixture was spray-dried to prepare second microcapsules. The drying parameters were set as follows: feed temperature 55°C, air inlet temperature 160°C, air outlet temperature 85°C, and spray pressure 0.2 MPa, to obtain powdery, easily dispersible second microcapsules.

[0227] This embodiment also discloses a method for preparing an orally disintegrating film, comprising the following steps:

[0228] S1: preparing core layer slurry;

[0229] Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and the first and second microcapsules according to weight, mix well, add PVP K25-anhydrous ethanol solution, and stir to form a uniform slurry;

[0230] S2: preparing the first attractant layer slurry;

[0231] Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry;

[0232] S3: preparing the second attractant layer slurry;

[0233] The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps;

[0234] S4: lamination film formation;

[0235] On the pre-treated film-forming substrate, the first attractant layer slurry, the core layer slurry and the second attractant layer slurry are spread in sequence to form a three-layer structure; the fixed thickness coating process is used to spread the slurry and control the thickness of each layer as follows:

[0236] First attractant layer: 50 μm;

[0237] Core layer: 100 μm;

[0238] Second attractant layer: 50 μm;

[0239] S5: hot pressing treatment;

[0240] The laminated film was hot pressed at 50°C and 0.1 MPa for 5 seconds.

[0241] S6: Drying treatment;

[0242] The hot-pressed film was dried at 40°C for 4 hours to control the moisture content of the film below 5%.

[0243] S7: Cutting and Packaging

[0244] Cut the dried membrane to ensure that the effective area of a single membrane is 5cm 2 , the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone;

[0245] Finally, the product is packaged and sealed to obtain the oral fast-dissolving film.

[0246] Example 6

[0247] The difference between Example 6 and Example 5 is that the first microcapsule further contains inulin and polyglutamic acid. The preparation method of the first microcapsule is as follows:

[0248] a1) 1 part chitosan was added to 100 parts by volume of a 1.5% aqueous acetic acid solution, and stirred at 400 rpm at 45° C. for 2 hours to completely dissolve the chitosan, thereby obtaining a transparent and uniform chitosan solution.

[0249] a2) 20 parts of a 2% inulin solution and 20 parts of a 1% polyglutamic acid solution were sequentially added to the chitosan solution, and the mixture was stirred for 30 minutes to form a ternary composite solution.

[0250] a3) Add 5 parts of active ingredient A or active ingredient B to the composite solution and continue stirring for 20 minutes to form a uniform suspension. The stirring temperature is controlled to not exceed 40°C to avoid inactivation of the active ingredient.

[0251] a4) adding the suspension dropwise to 100 parts of a 0.3 mol / L sodium hydroxide solution at a rate of 5 parts per minute, and slowly stirring at room temperature to achieve crosslinking and gelation to form first microcapsules with a certain particle size.

[0252] a5) The generated microcapsules were separated by filtration or centrifugation (3000 rpm, 10 minutes), washed three times with deionized water, and then vacuum-dried at 50° C. for 12 hours to obtain dried first microcapsules with good temperature and pH response.

[0253] Example 7

[0254] The difference between Example 7 and Example 6 is that a functional layer is provided between the core layer and the first attractant layer, and the functional layer is prepared by including the following raw materials in parts by weight:

[0255] Tea polyphenols: 3 parts;

[0256] Lactoferrin: 1.6 parts;

[0257] β-glucan: 4 parts;

[0258] Sodium bicarbonate: 5 parts;

[0259] Mannitol: 9 parts;

[0260] Soluble dietary fiber: 4 servings;

[0261] Gelatin: 3 parts;

[0262] Deionized water: 40 parts.

[0263] The preparation method of the oral fast-dissolving film comprises the following steps:

[0264] S1: preparing core layer slurry;

[0265] Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and the first and second microcapsules according to weight, mix well, add PVP K25-anhydrous ethanol solution, and stir to form a uniform slurry;

[0266] S2: preparing the first attractant layer slurry;

[0267] Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry;

[0268] S3: preparing the second attractant layer slurry;

[0269] The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps;

[0270] S4: preparing functional layer slurry;

[0271] Weigh tea polyphenols, lactoferrin, β-glucan, sodium bicarbonate, mannitol, soluble dietary fiber, and gelatin according to weight, add deionized water, and stir to mix to prepare a functional layer slurry;

[0272] S4: lamination film formation;

[0273] On the pre-treated film-forming substrate, the first attractant layer slurry, functional layer slurry, core layer slurry and second attractant layer slurry are spread in sequence to form a three-layer structure; the fixed thickness coating process is used to spread the slurry and control the thickness of each layer as follows:

[0274] First attractant layer: 50 μm;

[0275] Functional layer: 10 μm;

[0276] Core layer: 50μm;

[0277] Second attractant layer: 50 μm;

[0278] S5: hot pressing treatment;

[0279] The laminated film was hot pressed at 50°C and 0.1 MPa for 5 seconds.

[0280] S6: Drying treatment;

[0281] The hot-pressed film was dried at 40°C for 4 hours to control the moisture content of the film below 5%.

[0282] S7: Cutting and Packaging

[0283] Cut the dried membrane to ensure that the effective area of a single membrane is 5cm 2 , the edges maintain the staggered structure and heat-pressed bonding integrity.

[0284] The difference between Example 8-9 and Example 7 is that a functional layer is provided between the core layer and the first attractant layer. The functional layer of Example 8 is prepared by including the following raw materials in parts by weight:

[0285] Tea polyphenols: 1 part;

[0286] Lactoferrin: 0.5 parts;

[0287] β-glucan: 2 parts;

[0288] Sodium bicarbonate: 3 parts;

[0289] Mannitol: 5 parts;

[0290] Soluble dietary fiber: 2 servings;

[0291] Gelatin: 2 parts;

[0292] Deionized water: 30 parts.

[0293] The functional layer of Example 9 was prepared by including the following raw materials in parts by weight:

[0294] Tea polyphenols: 5 parts;

[0295] Lactoferrin: 3 parts;

[0296] β-glucan: 6 parts;

[0297] Sodium bicarbonate: 8 parts;

[0298] Mannitol: 15 parts;

[0299] Soluble dietary fiber: 6 servings;

[0300] Gelatin: 5 parts;

[0301] Deionized water: 60 parts.

[0302] Example 10

[0303] The difference between Example 10 and Example 7 is that an interface intermediate layer is further provided between the core layer and the first attractant layer. The raw materials of the interface intermediate layer include the following components in parts by weight:

[0304] Gelatin: 5-10 parts;

[0305] Polyvinyl alcohol: 2-8 parts;

[0306] Glycerin: 1-5 parts;

[0307] Deionized water: 30-60 parts.

[0308] The preparation method of the oral fast-dissolving film comprises the following steps:

[0309] S1: preparing core layer slurry;

[0310] Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and the first and second microcapsules according to weight, mix well, add PVP K25-anhydrous ethanol solution, and stir to form a uniform slurry;

[0311] S2: preparing the first attractant layer slurry;

[0312] Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry;

[0313] S3: preparing the second attractant layer slurry;

[0314] The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps;

[0315] S4: preparing functional layer slurry;

[0316] Weigh tea polyphenols, lactoferrin, β-glucan, sodium bicarbonate, mannitol, soluble dietary fiber, and gelatin according to weight, add deionized water, and stir to mix to prepare a functional layer slurry;

[0317] S5: preparing interface intermediate layer slurry;

[0318] Weigh gelatin, polyvinyl alcohol, and glycerin according to weight, add deionized water, and stir to mix to prepare an interface intermediate layer slurry;

[0319] S6: lamination film formation;

[0320] On the pre-treated film-forming substrate, the first attracting layer slurry, the interface intermediate layer, the functional layer slurry, the core layer slurry, the functional layer slurry, the interface intermediate layer and the second attracting layer slurry are spread in sequence to form a three-layer structure; the fixed thickness coating process is used to spread the slurry, and the thickness of each layer is controlled as follows:

[0321] First attractant layer: 50 μm;

[0322] Functional layer: 10 μm;

[0323] Interface middle layer: 5μm;

[0324] Core layer: 40μm;

[0325] Second attractant layer: 50 μm;

[0326] S7: hot pressing treatment;

[0327] The laminated film was hot pressed at 50°C and 0.1 MPa for 5 seconds.

[0328] S8: Drying treatment;

[0329] The hot-pressed film was dried at 40°C for 4 hours to control the moisture content of the film below 5%.

[0330] S9: Cutting and Packaging

[0331] Cut the dried membrane to ensure that the effective area of a single membrane is 5cm 2 , the edges maintain the staggered structure and heat-pressed bonding integrity.

[0332] Example 11

[0333] The difference between this embodiment and embodiment 10 is that step S7 in the method for preparing the orally disintegrating film is specifically as follows:

[0334] The laminated film was hot pressed at a temperature of 50° C. and a pressure of 0.5 MPa for 10 seconds to form a staggered laminated structure, a stepped edge, and a hot-pressed bonding zone.

[0335] Comparative Example 1

[0336] The difference between Comparative Example 1 and Example 1 is that no cross-linked polyvinylpyrrolidone is added to the core layer, and PVP K25-anhydrous ethanol solution is not used as the film-forming material. Instead, deionized water is used to directly prepare the core layer slurry. The other ingredients are the same. The specific composition is as follows:

[0337] The core layer includes the following components in parts by weight:

[0338] Sodium bicarbonate: 8 parts

[0339] Anhydrous citric acid: 10 parts

[0340] Lactose: 10 parts

[0341] 80-mesh sucrose powder: 5 parts

[0342] Aspartame powder: 0.1 part

[0343] Milk flavor essence: 0.1 parts

[0344] Active ingredient A: L-carnitine 3 parts, hawthorn extract 0.33 parts, taurine 3 parts, coenzyme Q10 0.03 parts, arginine 3 parts Deionized water (for slurry preparation): appropriate amount, prepared into a coating slurry

[0345] No PVP film-forming agent was used, and no cross-linked polyvinylpyrrolidone was added, resulting in poor stability of the film structure and a significant decrease in the fast-dissolving performance and mechanical properties.

[0346] The formulas of the first attractant layer and the second attractant layer are the same as those in Example 1.

[0347] The preparation method was the same as that in Example 1, except that water was used for slurry preparation in S1 without adding PVP K25-anhydrous ethanol solution and cross-linked polyvinylpyrrolidone.

[0348] Detection method

[0349] In order to evaluate the performance of the orally disintegrating film, the following method was used to test each embodiment and comparative example 1. The test results are shown in Table 1:

[0350] 1. Dissolution time (seconds): 5cm 2 The membrane was placed in a 37°C water bath and the time required for complete dissolution was recorded.

[0351] 2. Moisture content (%): Determined by oven drying method (105°C constant weight), control standard is ≤5%.

[0352] 3. Release rate of active ingredients (%): The membrane was dissolved in an artificial saliva system, and the release rate of the key active ingredients was determined by HPLC.

[0353] 4. Storage stability (relative activity retention, %): Accelerate storage at 40°C and 75% RH for 30 days and measure the active ingredient retention.

[0354] Table 1

[0355]

[0356] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiment. All technical solutions based on the concept of the present invention are within the scope of protection of the present invention. It should be noted that for those skilled in the art, various improvements and modifications that do not depart from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. An orally disintegrating film, characterized in that: The invention comprises a first attracting layer, a core layer and a second attracting layer which are arranged in sequence, wherein the core layer comprises the following components in parts by weight: An active ingredient selected from at least one of the following active ingredients A, B, C, and D, specifically: Active ingredient A includes 3 to 3.5 parts of L-carnitine, 0.33 to 0.35 parts of hawthorn extract, 3 to 3.5 parts of taurine, 0.03 to 0.035 parts of coenzyme Q10, and 3 to 3.5 parts of arginine; Active ingredient B includes 3-3.5 parts of soy lecithin, 3-3.5 parts of aloe vera extract, 0.03-0.035 parts of zinc gluconate, 0.03-0.035 parts of coenzyme Q10, and 0.33-0.35 parts of niacinamide; Active ingredient C includes 33.3-33.5 parts of beta-glucan and 33.3-33.5 parts of astragalus extract; Active ingredient D (a composition for improving bone and joint health) comprises 6-7 parts of glucosamine sulfate, 3-3.5 parts of chondroitin sulfate, 1.2-2 parts of drynaria extract, and 1.2-2 parts of soy isoflavones; and a PVP K25-anhydrous ethanol solution for film formation and bonding. The PVP K25-anhydrous ethanol solution is prepared by mixing 15 parts of PVP K25 with 67.4 parts of anhydrous ethanol, and the addition amount thereof is 10% to 30% of the total weight of the slurry.

2. The orally disintegrating film according to claim 1, wherein: The thickness of the oral fast-dissolving film is 20 μm to 200 μm.

3. The orally disintegrating film according to claim 1, wherein: The active ingredients include four active ingredients A, B, C, and D. The active ingredients A and B are pre-embedded into a first microcapsule using chitosan, and the active ingredients C and D are pre-embedded into a second microcapsule using starch.

4. The orally disintegrating film according to claim 3, wherein: The embedding material of the first microcapsule also contains inulin and polyglutamic acid, and the specific steps are as follows: a) dissolving chitosan in an acetic acid aqueous solution to obtain a chitosan solution; b) adding an inulin solution and a polyglutamic acid solution to the chitosan solution to form a chitosan-inulin-polyglutamic acid composite solution; c) adding the active ingredient A and / or active ingredient B weighed in proportion to the composite solution obtained in step b) and stirring to form a suspension; d) adding the suspension obtained in step c) dropwise to an alkaline coagulation solution to form microcapsules; e) washing and drying the obtained microcapsules to obtain active ingredient microcapsules with temperature-responsive and pH-responsive functions.

5. The orally disintegrating film according to claim 1, wherein: The first attracting layer and the second attracting layer are both prepared from the following raw materials in parts by weight: Chicken or duck powder: 5-15 servings Fish oil powder or shrimp powder: 2-10 parts Mannitol or xylitol: 5-10 parts Fat emulsion or lecithin: 1-5 parts Fructooligosaccharides: 3-8 parts Yeast extract: 0.1-1 parts Deionized water: 30-60 parts.

6. The orally disintegrating film according to claim 1, wherein: A functional layer is provided between the core layer and the first attractant layer, and the functional layer is prepared by comprising the following raw materials in parts by weight: Tea polyphenols: 1-5 parts Lactoferrin: 0.5-3 parts β-glucan: 2-6 parts Sodium bicarbonate: 3-8 parts Mannitol: 5-15 parts Soluble dietary fiber: 2 to 6 servings Gelatin: 2-5 parts Deionized water: 30-60 parts.

7. The orally disintegrating film according to claim 1, wherein: An interface intermediate layer is provided between the first attracting layer, the core layer and the second attracting layer. The raw materials of the interface intermediate layer include the following components in parts by weight: Gelatin: 5-10 parts; Polyvinyl alcohol: 2-8 parts; Glycerin: 1-5 parts; Deionized water: 30-60 parts; The thickness of the interface intermediate layer is 5 to 20 μm.

8. The orally disintegrating film according to claim 1, wherein: The oral fast-dissolving film adopts a staggered laminate structure, specifically comprising: a) The first attractant layer, the core layer, and the second attractant layer are stacked in sequence, with at least two interlaced sections, each of which is 20% to 50% of the total membrane length; b) In the staggered section, the first attractant layer extends beyond the core layer by 5 to 10 mm, and the second attractant layer extends beyond the core layer by 5 to 10 mm, forming a stepped edge; c) forming a hot pressing bonding belt in the staggered section, using a hot pressing process at 40-60° C., a pressure of 0.1-0.5 MPa, and a hot pressing time of 5-15 seconds; d) When the multilayer film is cut, the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone, and the effective area of a single film is 2 to 5 cm 2 .

9. A method for preparing an orally fast-dissolving film according to any one of claims 1 to 9, characterized in that: The following steps are involved: S1: preparing core layer slurry; Weigh sodium bicarbonate, anhydrous citric acid, lactose, 80-mesh sucrose powder, aspartame powder, milk flavor, cross-linked polyvinylpyrrolidone, and at least one active ingredient selected from active ingredients A, B, C, and D in parts by weight, mix well, add PVPK25-anhydrous ethanol solution, and stir to form a uniform slurry; S2: preparing the first attractant layer slurry; Weigh chicken meal or duck meal, fish oil powder or shrimp meal, mannitol or xylitol, fat emulsion or lecithin, oligofructose, and yeast extract according to weight, add deionized water, and stir to prepare a uniform slurry; S3: preparing the second attractant layer slurry; The second attractant layer slurry is prepared using the same formula and method as the first attractant layer slurry and the same steps; S4: preparing functional layer slurry; Weigh tea polyphenols, lactoferrin, β-glucan, sodium bicarbonate, mannitol, soluble dietary fiber, and gelatin according to weight, add deionized water, and stir to mix to prepare a functional layer slurry; S5: preparing interface intermediate layer slurry; Weigh gelatin, polyvinyl alcohol, and glycerin according to weight, add deionized water, and stir to mix to prepare an interface intermediate layer slurry; S6: lamination film formation; On the pre-treated film-forming substrate, the first attracting layer slurry, the core layer slurry and the second attracting layer slurry are sequentially spread to form a three-layer structure; S7: hot pressing treatment; The laminated film is hot-pressed at a temperature of 40 to 60° C. and a pressure of 0.1 to 0.5 MPa for 5 to 15 seconds to form a staggered laminated structure, a stepped edge, and a hot-pressed bonding zone. S8: Drying treatment; Dry the hot-pressed film at 40°C for 4 to 6 hours to control the moisture content of the film below 5%; S9: Cutting and Packaging Cut the dried film to ensure that the effective area of a single film is 2 to 5 cm 2 , the edges maintain the staggered structure and the integrity of the hot-pressed bonding zone; Finally, the product is packaged and sealed to obtain the oral fast-dissolving film.

10. The method for preparing an orally fast-dissolving film according to claim 9, wherein: In step S1, before adding active ingredient A and / or active ingredient B to the core layer slurry, first microcapsules are prepared in advance by the following microcapsule embedding method: a1) dissolving chitosan in an aqueous acetic acid solution to obtain a chitosan solution; a2) adding the inulin solution and the polyglutamic acid solution to the chitosan solution to form a composite solution; a3) adding active ingredient A and / or active ingredient B weighed in proportion to the composite solution and stirring to form a suspension; a4) adding the suspension dropwise to the alkaline coagulation solution to form first microcapsules; a5) washing and drying the obtained microcapsules to obtain first microcapsules with temperature-responsive and pH-responsive functions; In step a), the second microcapsules of active ingredient C and / or active ingredient D are prepared by the following method: a6) dissolving starch in deionized water to form a paste; a7) adding active ingredient C and / or active ingredient D weighed in proportion and stirring to form a mixed solution; a8) preparing second microcapsules by spray drying.

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